Packing device for articles requiring sterile and/or aseptic conditions



Aug. 29, 1967 R J, EDGWORTH ET AL 3,338,466

PACKING DEVICE FCE ARTICLES REQUIEINC sTERILE AND/CE ASEPTIC CONDITIONS Filed April l5, 1964 I N VE N TOR. RA' Y/V//VD JH/V EDG WOR TH ROBERT BARR/E CHR/S775 20 BYZ/cl E 5/ LJ,

United States Patent Oil 3,338,409' Patented Aug. 29, 1967 ice 3,338,400 PACKING DEVICE FOR ARTICLES REQUIRING STERILE AND/ R ASEPTIC CONDITIONS Raymond John Edgworth and Robert Barrie Christie,

Eastbourne, England, assignors to Armour Pharmaceutical Company, Chicago, Ill., a corporation of Delaware Filed Apr. 13, 1964, Ser. No. 359,215 9 Claims. (Cl. 20G-63.2)

The invention relates to art of packaging and more particularly to a device for packaging articles requiring sterile and/ or aseptic conditions such as surgical articles employed by the medical profession.

To provide a specific focus to both the problem and our solution, the invention will be considered with respect to surgical sutures and ligatures although it is to be understood that this is a setting rather than a limitation on our novel packaging device which is useful to package any article requiring a sterile and/or an aseptic environment.

In devices for packaging such articles, for example, surgical sutures or instruments, certain specific characteristics are desired which prior packaging devices have failed to attain.

For example, the sterilized condition within the packaging device must be maintained while the entry of contaminants into the packaging device must be prevented. Thus the device must be able to resist variations of climate and temperature and possess sutlicient structural strength to withstand handling both during shipping and storage, while being able to contain sharp surgical instruments, such as needles, knife blades, etc. without puncture. The device should also be sutilciently pliable to alleviate the danger of involuntary tearing and/or splintering Furthermore, the seal must be sufllciently stout to withstand even the most severe of shipping, storage and handling conditions.

A further characteristic desired in the packaging device is transparency sufficient to permit visual inspection and corroborative identification of its contents,'attendant respectively to quality control and use.

In addition such a package must be able to be easily and quickly opened without recourse to implements to permit the ready removal of its sterile contents without disrupting the sterility thereof.

The prior art has undergone a transition which has signicantly reduced the use of glass tubes for such packaging in favor of sachets of plastic, aluminum foil and aluminum foil compositions.

Such sachets are normally formed as an envelope of plastic, aluminum foil etc. by folding a sheet of the material into an overlapping position and then sealing the three open edges or by superimposing two sheets of the material, e.g., aluminum foil, aluminum foil compositions, etc.; and sealing all four open edges.

Another prior art sachet is formed by rolling a sheet of the material into a tube and sealing its ends.

All of these seals are effected by conventional means, such, for example as, adhesive bonding, heat sealing and the like.

In actual practice, particularly where rapid production is desired, the ldesign of the prior art packages presented several difficulties.-

Firstly, the disposition of the contents in a coplanar relationship to the seal frequently results in the contents, eg.v a-coiled suture being embedded in and entrapped by the seal thus impairing both the contents and the seal.

Secondly, in an attempt to obviate the foregoing difficulty, resort was made to the use of coil winders to which suture ends were fixed. The use of such winders suffered economically because of the additional cost of the winders and the additional labor unit cost because individual workers had to be more diligent in assuring that each suture was properly secured to its Winder.

Thirdly, the bulk of a coiled suture contained in a flat sachet is sufficient to cause distortion and stress on the seal resulting in a high proportion of packages which leak, both during manufacture and storage.

Fourthly, in packaging articles where a volatile and/ or inflammable sterilizing or conditioning fluid is needed, the heat of heat sealing induced combustion, as llashing or flaming, or volatilization within the package or within the area of heat seal, causing damage to the contents and the package. This disadvantage may be overcome by sealing in two operations but with consequent increase in labor unit cost.

Still another problem of prior art sachets occurs when it is desired to prepackage a complete suture and needle arrangement since these sachets are highly susceptible to puncture whereupon the sterility is lost. In order to overcome the problem of penetration, the prior art has adopted relatively thick laminated aluminum foil as a material for construction of sachets thereby losing the advantage of transparency of the package and increasing stress on the seal -due to distortion and creasing of the aluminum when enclosing a relatively bulky article.

Accordingly, a prime object of the present invention is to provide a new packaging device which substantially obviates all of the aforementioned disadvantages inherent in the prior art packaging devices.

Another important object of the present invention is to provide .a packaging device for packaging sterile surgical appliances which assures complete sterility and prevents the ingress of contaminants thereinto.

Another object of the present invention is to provide a novel packaging device which readily withstands handling of preparation, shipping and storage and resists the variations of climate and temperature resulting from world-wide use and modern air transportation.

Still another object of the present invention is to provide a novel packaging device may be used to package sharp and pointed objects without fear of puncture.

A still further object of the present invention is to provide a novel suture package in which a substantial portion or all the contents are completely visible both for quality inspection and corroborative identification.

Another object of the present invention is to provide a novel suture package in which the contained article or articles exert no stress on the perimeter seal of the package.

Other objects Iof the present invention include the provisions of a packaging device which is sufficiently ilexible to avoid splintering and yet suiiciently strong to permit reasonably rough handling, which precludes the unintentional egress of contents therefrom; is readily opened and permits ready removal of its contents; which is capable of incorporating a novel article holder and la-bel holder, neither of which obsecure the contained article from view; which can be readily opened without spillage; and which holds the contents in a position out of the plane of the seal.

These and still further objects as shall pear are fulfil-led by the present invention in a remarkably unexpected fashion as may be readily discerned from the following detailed description of embodiments exemplifying the invention, particularly when read in conjunction with the accompanying drawing in which:

FIG. l is a plan View of a packaging device embodying the present invention adapted for containing elongated articles;

FIG. 2 is a sectional View taken along line C-C of FIG. 1;

FIG. 3 is a cross sectional View taken along `the line A-A of FIGS. 1 and 4;

FIG. 4 is a plan view, partially broken away for clarity, of a packaging device embodying the present invention adapted for containing compact articles;

FiG. 5 is a plan view of still another packaging device embodying the present invention;

f FIG. 6 is a cross sectional View taken along line E-E of FIG. 5;

FIG. 7 is a plane elevation of the preformed flanged dished member of the present invention; and

FIG. 8 is a cross sectional view taken along the line D-D of FIG. 7.

Referring now to FIGS. 1 and 2, one packaging device embodying the present invention comprises a preformed flanged dish member 11, a sheet member 12, and a bridge 13 in co-operative co-action with each other in the manner to `be described.

Dish member 11, shown in detail in FIGS. 7 and 8, comprises a body portion 16 from which diverging side walls 18 and end walls 19 extend to an -outreaching flange 29 disposed peripherally thereto. One end 30 of ange 20 may be further extended for reasons hereinafter described.

In a preferred embodiment of the invention, each side wall 18 inwardly converging portions and an oif set portion 22 at about the mid-point thereto which bridge 13 can be attached, as will be explained, and which co-act with sheet member 12 to define holding area 32, the function of which will be also more fully explained. Also in this embodiment, flange 20 will be disposed in a plane generally parallel with the plane of body portion 16, while diverging walls 18 will define with the plane of body portion 16 an interior angle which is greater than normal and preferably about 130 to 150. The dish member 11 may be formed by pressing, blow moulding or vacuum forming a suitable material such, for example, as plasticized or unplasticised polyvinyl chloride, metal foil, plastic laminated `metal foil. When dish member 11, is formed of unplasticised or lightly plasticised polyvinyl chloride, it will have a thickness of at least 3 mils. and preferably of about 6 mils. thickness, although this thickness obviously can vary depending on the nature of the contents to be packaged therein.

Sheet member 12, may be formed of a plastic material similar to that used for dish member 11 although especially desirable results when sheet lmember 12 is formed of metal foil or of a metal foil laminated by a plastic film 28. Sheet member 12 thus provides an impermeable back to dish member 11, to which it is sealed by peripheral seal 31. To assemble the package, sheet member 12 is laid over dish member 11. Flange 20 and sheet member 12 are then lbonded together using suitable techniques such as radio frequency welding, adhesives, thermal sealing or the like, in a complete peripheral seal. Because of the spaced relationship between flange 20 and body portion 16, the use of thermal sealing poses none of the diiiiculties encountered when the article supporting surface, and the sealing plane are coplanar as in prior art.

Sheet member 12 and extending portion 30 of flange 20 are proportioned to extend axially beyond body portion 16, and dene a portion 24 which functions as means for opening the package as well as means for carrying a suitable label 29 upon which suitable identifying legends or symbols and the like may be attached or imprinted when the nature of the article packaged renders such identification desirable and/ or convenient.

T-o facilitate the rapid and convenient opening of the sealed package without disrupting the contents thereof, a tear notch 26, preferably V-shaped is disposed, in sheet member 12 and ange 20 partially across perimeter seal 31 adjacent to the end of body portion 16. In a preferred practice, tear notch 26 is cut into the outer edge of the shaped perimeter seal 31, so that the apex of the V is in line with the short edge of body portion 16, that is, in line with that edge of body portion 16 contiguous with extending portion 30l of flange 20. As the preferred materials of construction are notch sensitive, the package may only be torn open at this point and in a predetermined direction across the edge of adjacent ange portion 20. Thus, the package can always be readily opened without damage to its contents. Once opened, the rigidity of dish member 11 maintains the remainder of sheet 12 in Contact with it to keep the article-containing portion of dish member 11 closed until the long sides of the package are squeezed gently together as by gripping the holding areas 32 between the thumb and forefinger. Thus, even though the seal has been broken (usually in the operating theatre), the contents remain protected from aerial bacterial contamination, solid contents cannot be spilled, and liquid contents may be easily retained, if so required. When desired, to remove the article it is a simple operation to squeeze the `long sides of the package and remove the article with suitable lifters, such, for example, as forceps.

It is apparent that in the event that the article to be packaged is of such nature that label identification is not required or that only simple identification is all that is desired, extending portion 24 can be ysubstantially reduced in its relative size as shown in FIGS. 5 and 6.

Bridge 13 is formed of an elongated strip which may be disposed transversely of body porti-on 16 at about the middle thereof with slight slack and is sealed at its ends to portion 22, hereinafter called bridge locating flange, of dish member 11. If desired, bridge 13 may be sealed to sheet 12 in such a position that it will be located centrally to body portion 16 when the latter is sealed to sheet 12 by peripheral seal 31. It has been found a relatively easy matter to locate bridge 13 relative to body portion 16 by using holding means 32, when present, as indicia of position.

Bridge 13 preferably coacts with dish member 11, but if so desired, with sheet member 12, to provide a holding passageway into which the article to be contained is inserted. This article is exemplified in the drawings as a surgical suture with and without an attached needle. In one successful practice of this invention bridge 13 is formed as a strip of vinylidene-laminated aluminum foil which is extended between portions 22 of dish member 11.

When articles not requiring special holding are to be packaged, bridge 13 can be omitted and the invention practiced in the manner illustrated in FIGS. 5 and 6. Preferably, however, the package is especially well suited for packaging surgical sutures and ligatures and bridge 13 is an essential and salient feature of its construction when so employed.

Various well known methods of sterilization can be employed with this package, for example: the dish containing the unsterile article may be filled with a suitable sterilizing fluid and the sheet member sealed to the dish member; or the dish containing the unsterile article may be filled with a suitable alcoholic conditioning uid, the sheet member sealed to the dish member, and the entire package sterilized by gamma irradiation; or the component parts of the package lmay be sterilized by gamma irradiation or by chemical means and thereafter aseptically assembled to contain a heat sterilized article; and the like.

To open the packaging device of this invention, the user (usually a physician, or a surgeon or his aide) merely grips extending portion 24 in one hand and body portion 16 in the other and gently tears at tear notch 26 to separate the article holding portion of the package from portion 24. This is accomplished with the packaging device in a vertical position whereupon the package is readily opened without spilling the liquid contents. If desired, the package may be placed on a flat surface with body member 16 downwards, whereby no spilling of liquid contents will occur.

After the packaging device has been thus opened, the article disposed therein is readily removed by gently squeezing together the opposing peripherally sealed sides and `thereafter withdrawing the article therefrom with forceps or other suitable lifting devices.

In preferred embodiment of this invention for suture packaging, the metal foil employed in the pack will be aluminum. Aluminum is inexpensive, exhibits especially desirable properties in preventing moisture loss, and permits an accurate water balance to be maintained inside the package, which is needed to assure desired exibility of the suture.

Although the preferred embodiments herein described and illustrated comprise a substantially transparent dish member 11 and an opaque sheet member 12, it is understood that the dish member could be opaque and the sheet member transparent, if desired, in which instance substantially co-mplete visibility of contents is still obtained by again associating the bridge with the transparent member, in this case the sheet member, to hold the article.

From the foregoing it can be seen that the packaging device herein described ,and illustrated fulfills all of the aforestated objects to a remarkably unexpected degree. It is, of course, understood that the foregoing description and illustration is presented only as exempliiication and not as limitation and that such other applications, modifications and alterations as readily occur to the artisan from a consideration of this desclosure are intended within the spirit of this invention, especially as it is defined by the scope of the claims appended hereto.

What is claimed is:

1. A packaging device for articles requiring sterile conditions comprising: a relatively shallow open dish member having a body portion having a uniformly flat surface and outreaching and extended ange portions; a sheet member disposed across said dish member in generally parallel spaced relationship to said iiat surface in sealed engagement with the periphery of said iiange portions; and a bridge member comprising an elongated strip having first and second ends interposed between and secured by said engagement and extending transversely of said dish member and said sheet member, said bridge member co-acting with one of said last named members to define an article holder therewith.

2. A device according to claim 1 in which one of said members co-acting with said bridge member is transparent.

3. A device according to claim '1 in which said brid-ge member extends transversely of said dish member and co-acts therewith to define said article holder.

4. A device according to claim 1 in which said bridge member extends transversely of said sheet member and co-acts therewith to define said article holder.

5. A device according to claim 1, in which said dish member includes diverging walls interposed between said body portion and said liange portions.

6. A packaging device according to claim 5 in which said diverging Walls define an interior angle greater than normal with the plane of the body portion.

7. A device according to claim 6 in which said interior angle is between and 150.

8. A packaging device for articles requiring sterile conditions comprising a relatively shallow open dish member having a body portion having a uniformly flat surface, outreaching and extended flange portions, a surgical article disposed in said dish member and a sheet member disposed in superposition to said flat surface and in peripheral sealing engagement with said liange portions and immobile relative thereto, said sheet member having a. cover portion enclosing said dish member and an extending portion disposed from said cover portion in the same plane therewith, said extending portion of said sheet member carrying a descriptive label which does not obscure the contents of said dish member, said device having a V-notch incorporated in the peripheral seal to ensure opening by tearing in a predetermined direction along the edge of a flange portion of said dish member.

9. A packaging device according to claim 1 containing a surgical device.

References Cited UNITED STATES PATENTS 2,893,546 7/ 1959 Kendall et al. 206-46 3,034,640 5/ 1962 Evans 206-4534 3,084,793 4/ 1963 Pitman 206 63.2 3,178,019 4/ 1965 Fetzek. 3,182,790 5/1965 Bieganousky et al. 206-45.34 X

FOREIGN PATENTS 1,257,115 2/1961 France. 1,333,195 6/1963 France.

LOUIS G. MANCENE, Primary Examiner. 

1. A PACKAGING DEVICE FOR ARTICLES REQUIRING STERILE CONDITIONS COMPRISING: A RELATIVELY SHALLOW OPEN DISH MEMBER HAVING A BODY PORTION HAVING A UNIFORMLY FLAT SURFACE AND OUTREACING AND EXTENDED FLANGE PORTIONS; A SHEET MEMBER DISPOSED ACROSS SAID DISH MEMBER IN GENERALLY PARALLEL SPACED RELATIONSHIP TO SAID FLAT SURFACE IN SEALED ENGAGEMENT WITH THE PERIPHERY OF SAID FLANGE PORTIONS; AND A BRIDGE MEMBER COMPRISING AN ELONGATED STRIP HAVING FIRST AND SECOND ENDS INTERPOSED BETWEEN AND SECURED BY SAID ENGAGEMENT AND EXTENDING TRANSVERSELY OF SAID DISH MEMBER AND SAID SHEET MEMBER, SAID BRIDGE MEMBER CO-ACTING WITH ONE OF SAID LAST NAMED MEMBERS TO DEFINE AN ARTICLE HOLDER THEREWITH. 